Phase 1 Study of ELVN-001 Treatment for Chronic Phase Chronic Myeloid Leukemia With or Without T315I Mutation in Japanese Adults

What this Trial Is About

Researchers are evaluating ELVN-001 in Japanese adults with chronic phase chronic myeloid leukemia CML, including those with or without the T315I mutation. The study focuses on patients who have not responded to, cannot tolerate, or are not candidates for at least two prior tyrosine kinase inhibitors TKIs. This phase 1 trial aims to assess the safety, tolerability, and appropriate dosing of ELVN-001 for future clinical use, while also monitoring changes in the BCR-ABL1 transcript to understand the drugs impact on CML. The study involves two parts an initial dose escalation phase where ELVN-001 is given orally once or twice daily to small groups of participants to identify safe and tolerable doses. Following this, a dose exploration phase will enroll participants at or below these dose levels to further evaluate safety and dosing. The treatment is administered continuously, with careful monitoring for adverse events and laboratory abnormalities. Participants will undergo regular evaluations including safety assessments, laboratory tests, and electrocardiograms ECGs for up to three years. Researchers will measure dose-limiting toxicities, adverse events, and specific molecular responses related to CML. Pharmacokinetic parameters such as concentration levels of ELVN-001 will also be studied over six months. This long-term follow-up aims to understand the drugs effects and safety profile comprehensively during and after treatment.

ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants